1. Field of the Invention
The present invention relates generally to the fields of microbiology, medicine and hygiene. More particularly, it concerns antiseptic compositions that may be used, in certain embodiments, for skin disinfection and/or skin antisepsis.
2. Description of Related Art
Antiseptics are crucial for the practice of medicine; however, currently used antiseptics have a significant failure rate which results in substantial additional medical costs. Antiseptics are commonly used prior to routine phlebotomy, in preparation for minor and major invasive procedures, and as part of routine infection control hand-washing practices. The failure of antiseptics often result in nosocomial infections and erroneous diagnostic tests. For example, it has been estimated that a single false positive blood culture (i.e., where the culture indicates that the blood has been infected with bacteria, although the blood was contaminated during the blood draw) done on blood drawn from a patient at a hospital costs the patient an additional $2000 to $4,200 in unnecessary medication, additional follow up testing, and increased length of stay. (Bates, 1991).
Attempts have been made to improve antiseptics. For example, skin antisepsis has been performed using 70% isopropyl alcohol containing either 2% chlorhexidine gluconate or 2% tincture of iodine (Trautner et al., 2002). Bacterial decontamination of skin, however, is difficult to achieve. For example, bacteria can colonize sweat glands, hair follicles, and become sequestered in layers of dead keratinized skin. Thus, there remains a significant need for improved antiseptics.
An improved antiseptic could lower rates of wound infection, catheter infection, and blood culture contamination, as well as reduce nosocomial contamination introduced from health care worker hands. Although rare, routine phlebotomy carries some finite risk of cellulitis. Thus, an improved antiseptic may become the standard even in standard procedures such as routine phlebotomy.
Higher concentrations of DMSO have been previously used for delivery of therapeutic compositions. U.S. Pat. No. 3,671,654 describes compositions comprising a diester of 2,2,4-trimethylpentanediol-1,3, an aliphatic carboxylic acid of 2 to 12 carbon atoms, a lower concentration of alcohol (e.g., 5% to 30%) and DMSO (e.g., 50% DMSO) for the treatment fungal or bacterial infections. DMSO, at concentrations of 50% or greater, is a common carrier used to get deep penetration of topical pharmaceuticals into the dermis and facilitate the absorption of drugs (Wilson et al., 1965). DMSO, has also been associated with anti-inflammatory effects.
Specifically, there is a clinical need for improved skin antiseptics. Current skin antiseptics have a significant failure rate, with adverse impact on surgical wound infection rates and infection control generally. Between 3 and 7% of blood cultures obtained in the U.S. become contaminated with skin flora at the time of phlebotomy with an associated cost of approximately $1 billion. Clean surgical wound contamination is a major problem and is largely due to the failure of skin antisepsis. In spite of this there have been only minor improvements in the performance of skin antiseptics in recent years. (whqlibdoc.who.int/publications/2003/9241562463.pdf; www.ahrq.gov/data/hcup/hcupnet.htm; CDC Advance Vol 329: Jun. 19, 2002; Boyce, 2001)